The FDA's New CSA (Computer Software Assurance) requirements

The New CSA requirements per the FDA's new guidance document can be summed up as follows:  Computer software assurance focuses on preventing the introduction of defects into the software development cycle and it encourages the use of a risk-based (patient / user) approach to establish confidence that software is fit for its intended use.

- jel@jelincoln.com  02/12/2026